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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 12 Results
ProductCode: GGN Applicant: INSTRUMENTATION LABORATORY CO. Decision Date To: 09/24/2024
 
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hemosil acustar hit-igg(pf4-h), hemosil acustar hit controls Instrumentation Laboratory Co. K170854 09/08/2017
hemosil la positive control & hemosil la negative control INSTRUMENTATION LABORATORY CO. K113211 01/04/2012
hemosil la positive control INSTRUMENTATION LABORATORY CO. K102552 04/05/2011
hemosil d-dimer hs 500, controls INSTRUMENTATION LABORATORY CO. K090264 02/05/2010
hemosil inr validate, hemosil isi calibrate, isiweb (software) INSTRUMENTATION LABORATORY CO. K090563 10/09/2009
hemosil liquid heparin, heparin calibrators and lmw and uf heparin controls INSTRUMENTATION LABORATORY CO. K090209 06/02/2009
acl acustar, hemosil acustar d-dimer, hemosil acustar d-dimer controls INSTRUMENTATION LABORATORY CO. K083518 03/13/2009
hemosil routine control level 1, level 2, level 3 unassayed INSTRUMENTATION LABORATORY CO. K082859 12/19/2008
control plasma lmw heparin INSTRUMENTATION LABORATORY CO. K030965 06/06/2003
hemosil high abnormal control assayed INSTRUMENTATION LABORATORY CO. K021024 05/16/2002
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